Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: PL3994

Detailed Description

Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
• Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
• Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.

Exclusion Criteria:

• Subject weight greater than 100 kg or less than 50 kg.
• Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: PL3994 Dose A	Drug: PL3994; Study drug
Experimental: PL3994 Dose B	Drug: PL3994; Study drug
Experimental: PL3994 Dose C	Drug: PL3994; Study drug
Experimental: PL3994 Dose D	Drug: PL3994; Study drug
Experimental: PL3994 Dose E	Drug: PL3994; Study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.	The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.	24 hours
Pharmacodynamics as Measured by cGMP Levels.	Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.	24 hours

Collaborators and Investigators

• Sponsor: Palatin Technologies, Inc
• Investigators: Study Director: Robert Jordan, Palatin Technologies, Inc; Study Director: Steven Fischkoff, MD, Palatin Technologies, Inc

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (Estimate): May 30, 2008

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 8, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: hypertension; hypertensives; controlled hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PL3994-003